NCT01890395

Brief Summary

To identify patients who may be predisposed for developing MOF (multiple organ failure)by the sampling of blood.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 1, 2013

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

August 17, 2018

Status Verified

August 1, 2018

Enrollment Period

7 years

First QC Date

June 26, 2013

Last Update Submit

August 15, 2018

Conditions

Keywords

mitochondrial DAMPS

Outcome Measures

Primary Outcomes (1)

  • correlation mitochondrial damps (mDAMPS) and multiple organ system failure

    Preliminary studies (at University of South Alabama)in the trauma and burn patients indicate that the level of mitochondrial damps are highly correlated with non-survival; that is, they reflect a massive trauma. They also reflect patients that have a propensity to go into multiple system organ failure. We believe that these measurements in our surgical patients will also reveal many of the same correlations with the correlation between microvascular circulation and the mitochondrial damps.

    1 year

Study Arms (1)

blood collection

OTHER

procedure: Blood draws as the intervention

Other: Blood draws

Interventions

Blood sampling collected at 9 timepoints: pre-operative, during surgery X 3, immediately after surgery, 24 hrs post-op, 72 hrs post-op, 5 days and 7 days post

blood collection

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients @ USAMC undergoing surgical operations expected to have microcirculatory changes, i.e., CABG, open heart, aortic or other revascularizing operations, general surgical operations such as colon resections, bowel resections or any other surgical procedures in which the subject could be expected to or might develop multiple system organ failure.

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Alabama Medical Center

Mobile, Alabama, 36617, United States

RECRUITING

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • William O. Richards, MD

    University of South Alabama, Department of Surgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

William O. Richards, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 26, 2013

First Posted

July 1, 2013

Study Start

December 1, 2012

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

August 17, 2018

Record last verified: 2018-08

Locations